Addressing competition concerns, reimbursement plans, and integration platforms are the keys to advancement

Digital health has become an increasing trend that is being used to proactively prevent illness. Adopting digital data analysis allows the early detection of disease, which decreases potential future risks. This is according to the "Taiwan Digital Health Report – Considerations for fostering the best ecosystem," which was released today by the European Chamber of Commerce Taiwan (ECCT) and SANOFI. The report examines the missing links in existing structures and the efforts required to propel the digital health industry in Taiwan. It also provides suggestions to support a consolidated, collaborative, and risk-based model to foster digital health innovation, based on experiences from the US, Germany, France, and the UK.

Germany is the first country in the world allows doctors to prescribe digital health applications. The key to its success is the support given by healthcare authorities to DiGA (Digital Health Applications), which acted as a catalyst for the digital transformation. During the first year of launch, over 50 medical apps and roughly 73 million individuals benefited from this certification process. These digital solutions have been implemented in disease areas such as obesity, depression, and sleep disorders. While Taiwan has the advantage of a sophisticated information and communications technology (ICT) industry and a mature healthcare environment, it still faces many unmet needs in developing digital health.

The report was released at an ECCT Premium Event luncheon which was attended by senior Taiwan government officials and international healthcare experts. At the event, Dr. Po-Chang Lee, Director General of the National Health Insurance Administration under Taiwan's Ministry of Health and Welfare (NHIA, MOHW, 健保署署長李伯璋) and Dr. Shiou-Mei Wu, Director General of Taiwan's Food and Drug Administration (FDA, MOHW, 食藥署署長吳秀梅) represented the government as speakers and panelists. The report was introduced by Dr. Hasnaa Fatehi, Founder of QARALOGIC Consulting, after which Anthony Jones, Head of Virtual Healthcare at Sanofi, gave a presentation. The event concluded with a panel discussion moderated by Dr. Hasnaa Fatehi featuring all of the speakers as well as additional panelists Jorge Wagner, General Manager of Novartis (Taiwan) and Ed Deng, CEO of Health2Sync.

Bottleneck of Taiwan digital health software: Difficult approval process and unclear reimbursement criteria
The report highlights the challenge of real-world data application, regulatory approval, and reimbursement issues, concluding that it is necessary to undertake a digital health transformation after the Covid-19 outbreak.

According to ICLG, the International Comparative Legal Guides, there is no clear definition of "digital health" under Taiwan law. So far, only three Software as Medical Device (SaMD)-based digital health solutions have been approved in Taiwan and requirements are getting more stringent. As the result, digital health start-ups may have to first secure a US FDA clearance and then use that to obtain Taiwan FDA approval, which makes the entire process more difficult.

Furthermore, the regulatory pathways for digital health device commercialisation in Taiwan remain unclear. For this reason, people are unlikely to get new, non-reimbursable medical devices and technologies under the sole health insurance system. Digital health solutions which are being actively developed now, are likely to continue to face hurdles if the government fails to improve the reimbursement structure.

Four key considerations in the report
While Taiwan has one of the best healthcare systems in Asia, with extensive data management systems, it does not yet have in place regulations specific to digital health. Based on the experiences of leading digital health markets in the US, Germany, France and the UK, the report provides four suggestions:

1. Creation of a cross-agency advocate within the government focused on digital health.
2. Creation of an e-health platform, a one-stop shop for manufacturers, regulators, insurers, and other players to work together to support digital health innovators.
3. Establishment of a road map for development, certification, approval, and reimbursement specific to digital therapeutics (DTx) solutions
4. Definition of pre- and post-market regulations designed to support the quick launch of digital solutions while ensuring patient-centricity.

Learn from leading markets to consolidate digital health data and overcome regulatory hurdles
For digital health to be successful, digital health and Real World Evidence (RWE) need to evolve interdependently with each other. The topic relates to payers and insurers, and has to address issues ranging from easing patients' concerns about sharing data, to regulator/insurer positions on "digitally derived endpoints" to a lack of regulatory clarity regarding RWE requirements.

In addition to the successful case of Germany (cited above), the paper mentions a functional classification system developed in the UK with the intention of providing a pragmatic approach to differentiating the digital health technologies on the basis of functions that are expected to be most widely developed and used. Taiwan could leverage its advantage of a tech-savvy population and mature health-care system, while also learning from others, in order to accelerate the launch and reimbursement of innovative digital health.

The report recommends ways to accelerate digital health development including improving the reimbursement structure, building an e-Health cross-agency platform, and fostering collaboration within the ecosystem. It concludes that this would not only reduce the healthcare expenditure burden, fuel biomedical innovation, and support patients, but would also be aligned with the goals of Taiwan's "5+2 Industrial Innovation Plan" and the "Six Core Strategic Industries initiative".

歐洲商會與賽諾菲共同發表台灣數位醫療報告書

台灣仍存在競爭隱憂   訂定給付補助計畫以及建構整合平台為推進關鍵
歐洲在台商務協會與賽諾菲於今日（ 12月7日）共同發表的「台灣數位醫療報告書- 邁向最佳數位醫療生態系統」指出，數位醫療已成預防醫學趨勢，透過數據運用分析，得以即時獲得警訊，降低疾病發生風險。這份報告書檢視並探討現狀的不足與隱憂，以及台灣推動數位醫療產業所需的努力。同時根據美、德、法、英四國經驗，提出數位醫療創新模型，來支持數位醫療創新整合、合作、風險管理。

德國是第一個可開立數位醫療處方的國家，其成功關鍵在於衛生主管機關對DiGA (Digital Health Applications)條例的支持，該條例生效第一年，幫助超過50款健康醫療軟體申請上市，嘉惠約7300 萬名德國民眾，應用於肥胖、憂鬱症、睡眠障礙等疾病。台灣雖擁有卓越資通訊技術及成熟健保環境，卻面臨許多未被滿足的需求。

這份報告書於歐洲商會舉辦的菁英午餐會發布，與會者包含台灣政府代表以及跨國醫療保健專家。健保署署長李伯璋以及食藥署署長吳秀梅為在場的政府代表，擔任講者以及論壇與談人。此份報告書內容由作者、QARALOGIC Consulting創辦人Dr Hasnaa Fatehi介紹，接著賽諾菲香港台灣數位醫療保健處長Anthony Jones發表演說，最後進行由Dr. Hasnaa Fatehi所主持的論壇討論，與談人包括前述講者及台灣諾華總經理Jorge Wagner以及智抗糖創辦人Ed Deng。

醫療器材軟體在台面臨障礙 主因為申請過程困難 給付不明確
COVID-19爆發後，數位醫療轉型勢在必行，台灣數位醫療報告書指出，數位醫療目前面臨的挑戰，包含真實世界數據的運用、上市許可及給付申請等問題。

根據法規參考平台ICLG指出，台灣的法律目前對「數位醫療」缺乏明確定義，而目前台灣僅核准三項醫療器材軟體(SaMD)。目前觀察到台灣許可證申請更趨嚴格，因此數位醫療新創公司可能採取先取得美國FDA核准的策略，這使得許可證申請過程更加不易。

再者，數位醫療器材之健保給付補助方案與標準尚不明確，加上健保系統體系下，民眾不太可能取得健保未給付的新醫療器材與科技。若政府無法改善健保給付補助結構，那麼此刻正在積極研發的數位醫療解決方案，可能會繼續窒礙難行。

數位醫療報告書四大關鍵考量
儘管台灣具有亞洲最佳的醫療保健系統之一，具備大量數據管理系統(例如全民健康保險集中資料庫)，但數位醫療特定規範卻仍未到位。根據美國、德國、法國以及英國等數位醫療領導市場所採取計畫，台灣數位醫療報告書提出以下四項建議及關鍵考量：

1. 在政府機關內建立數位醫療的跨機構倡議。
2. 建立一站式的電子健康(e-Health)平台，可讓製造商、法規機關、保險公司與其他參與者攜手合作，支持數位醫療創新
3. 針對數位醫療解決方案，製作發展、認證、核准與健保給付補助的路線圖
4. 明確定義數位解決方案上市前後的法規，加速上市的同時，確保以病患為中心的理念

借鏡經驗 整合數位醫療數據 破除法規瓶頸
數位醫療要成功，必須整合來自數位醫療的臨床數據不斷創新演化，其資訊與支付單位、保險公司以及法規機構的決策程序息息相關，包含患者是否願意分享數據、法規機構或保險公司對於「數位衍生指標」的接受度，證明真實世界數據在數位醫療運用，仍面臨諸多挑戰。

報告書列舉先進市場之成功經驗，除上述德國案例，英國也在數位醫療科技以功能分類，明確地指出不同功能所需要的證據等級，幫助製造商開發出可被廣泛使用的數位醫療軟體。台灣的製造能力與食品藥物管理署的成熟度，再結合他國成功經驗，有助於創新數位醫療取得健保給付與食品藥物管理署核准上市。

報告書中更呼籲，改善整體健保給付補助結構是推動數位醫療之關鍵，建立倡導跨機構數位醫療的電子健康平台，促進數位醫療生態系統內之交流與合作。這不僅可降低醫療保健支出，推動生醫創新並支持患者，也符合台灣的「五加二產業創新計畫」與「六大核心策略產業」目標。